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Alkermes和Biogen宣布美国FDA接受了Diroximel富马酸盐治疗多发性硬化症的新药申请


2019-02-26 不详 网络

Alkermes公司和Biogen公司近日宣布美国食品和药品监督管理局(FDA)已接受Diroximel富马酸盐治疗多发性硬化症(MS)的新药申请(NDA)。

Alkermes公司和Biogen公司近日宣布美国食品和药品监督管理局(FDA)已接受Diroximel富马酸盐治疗多发性硬化症(MS)的新药申请(NDA)。Alkermes的药品开发和医疗事务及首席医疗官兼高级副总裁Craig Hopkinson博士说:“Diroximel富马酸盐的NDA申请的接受进一步证明了AlkermesBiogen之间的高效合作,使我们更接近为MS患者提供新治疗选择的共同目标。我们相信Diroximel富马酸盐有可能为MS患者提供有意义的治疗选择,我们期待在整个审查过程中继续与FDA合作

多发性硬化症(Multiple SclerosisMS)是一种慢性、炎症性、脱髓鞘的中枢神经系统疾病。可引起各种症状,包括感觉改变、视觉障碍、肌肉无力、忧郁、协调与讲话困难、严重的疲劳、认知障碍、平衡障碍、体热和疼痛等,严重的可以导致活动性障碍和残疾。


原始出处:

http://www.firstwordpharma.com/node/1626641#axzz5gd5Pbuy9

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    2020-01-19 sunylz
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    2019-10-25 jml2009
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    2019-02-28 qjddjq
  6. [GetPortalCommentsPageByObjectIdResponse(id=1983047, encodeId=8f59198304e3f, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Tue Jun 18 00:11:00 CST 2019, time=2019-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918556, encodeId=625f191855680, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Sun Jan 19 20:11:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1744182, encodeId=a86a1e4418248, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Mon Apr 15 16:11:00 CST 2019, time=2019-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889990, encodeId=1b6118899903b, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Fri Oct 25 21:11:00 CST 2019, time=2019-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1404334, encodeId=8b82140433474, content=<a href='/topic/show?id=a4f13430af' target=_blank style='color:#2F92EE;'>#Biogen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3430, encryptionId=a4f13430af, topicName=Biogen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0dab2457651, createdName=qjddjq, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551429, encodeId=232a15514295c, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590804, encodeId=92391590804d7, content=<a href='/topic/show?id=0c0b115e4cf' target=_blank style='color:#2F92EE;'>#MES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11574, encryptionId=0c0b115e4cf, topicName=MES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=874617863969, createdName=longqijun254, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1983047, encodeId=8f59198304e3f, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Tue Jun 18 00:11:00 CST 2019, time=2019-06-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918556, encodeId=625f191855680, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Sun Jan 19 20:11:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1744182, encodeId=a86a1e4418248, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3c35313981, createdName=wangbingxhy, createdTime=Mon Apr 15 16:11:00 CST 2019, time=2019-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889990, encodeId=1b6118899903b, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Fri Oct 25 21:11:00 CST 2019, time=2019-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1404334, encodeId=8b82140433474, content=<a href='/topic/show?id=a4f13430af' target=_blank style='color:#2F92EE;'>#Biogen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3430, encryptionId=a4f13430af, topicName=Biogen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0dab2457651, createdName=qjddjq, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551429, encodeId=232a15514295c, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590804, encodeId=92391590804d7, content=<a href='/topic/show?id=0c0b115e4cf' target=_blank style='color:#2F92EE;'>#MES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11574, encryptionId=0c0b115e4cf, topicName=MES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=874617863969, createdName=longqijun254, createdTime=Thu Feb 28 13:11:00 CST 2019, time=2019-02-28, status=1, ipAttribution=)]
    2019-02-28 longqijun254
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